Atorvastatin for Prevention of Amikacin-induced Electrolytes Imbalances; a Randomized Clinical Trial

Abstract

Aminoglycosides are still widely used for treatment of gram-negative sepsis in critically ill patients. The most reported electrolyte abnormalities related to these drugs are hypokalemia, hypomagnesemia, and hypocalcemia. In this study potential benefit of atorvastatin in prevention of amikacin-induced electrolytes imbalances has been evaluated. In this trial 44 patients were assigned to the atorvastatin or placebo group based on the simple randomization method. Atorvastatin group received amikacin with dose of 15 mg/kg/day in two equal divided doses every 12h as intravenous infusion during 30 minutes and atorvastatin 40 mg tablet as daily oral dose for 7 days. Patients in the placebo group received same dose of amikacin and placebo tablet (Placebo group) for at least 7 days. Serum electrolytes (sodium, potassium, calcium, phosphor and magnesium) concentrations, blood urea nitrogen and serum creatinine levels were measured at day 0 and end of the study. Baseline mean±SD of serum potassium concentration in the atorvastatin and placebo group was 4.07± 0.37 and 4.15 ± 0.53 meq/l respectively (p=0.88). Serum potassium concentration remained unchanged at the end of the study in the atorvastatin group (P=0.61) but significantly decreased from 4.15 ± 0.53 to 3.80 ± 0.55 meq/l in the placebo group at day 7(P = 0.02). In this pilot study, atorvastatin as 40 mg daily oral dose prevented renal potassium loss during course of amikacin therapy in the critically ill patients. In the future well designed randomized clinical trials with adequate sample size, renoprotective effects of statins should be examined.